Cardiac Arrest, Extracorporeal Circulation; Complications, Hemodynamics Instability, Shock, Cardiogenic
Conditions
Brief summary
The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is: * Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on hemodynamics and organ perfusion. Participants require VA ECMO support, will be divided into two groups in an intention-to-treat analysis: central artery cannulation and peripheral artery cannulation. Researchers will analyze different cannulation strategies for VA-ECMO and identify potential advantages and disadvantages for two groups of VA-ECMO.
Interventions
Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is mainly used for circulatory support in patients with severe cardiopulmonary failure. VA ECMO drains the blood from the venous system followed pumping the blood back into the arterial vascular compartment after oxygenation. It can be divided into two cannulation strategies for VA ECMO support, namely peripheral VA ECMO and central VA ECMO based on the arterial cannulation site. Peripheral VA ECMO is established via the femoral artery (FA), whereas axillary artery (AX) is an arterial cannulation site in central VA-ECMO.
Sponsors
Peking University Third Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing Anzhen Hospital
Guangdong Provincial People's Hospital
Shaanxi Provincial Center for Disease Control and Prevention
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥18 years * Participants with cardiogenic shock * Obtaining informed consent from participants or their affiliated beneficiaries
Exclusion criteria
* Irreversible heart failure * Contraindications to anticoagulation therapy * Uncontrolled bleeding * Irreversible neurological pathology * Participants limited to extracorporeal cardiopulmonary resuscitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mitral valve area(cm2) | Through VA ECMO support completion, an average of 1 week | echocardiography |
| Oxygen saturation-no. (%) | Through VA ECMO support completion, an average of 1 week | Blood gas analysis |
| Left ventricular end-diastolic volume (ml) | Through VA ECMO support completion, an average of 1 week | echocardiography |
| Left ventricular End-systolic volume (ml) | Through VA ECMO support completion, an average of 1 week | echocardiography |
| Stroke volume (ml) | Through VA ECMO support completion, an average of 1 week | echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful weaning from VA ECMO | Through study completion, up to 2 years | Weaning success is defined as survival after complete removal of the extracorporeal circuit without requirement for further mechanical support or heart transplant. |
| VA ECMO duration | Through VA ECMO support, an average of 1 week | Length of VA ECMO support |
| Cannulation-related complications | Through study completion, up to 2 years | Cannulation-related complications include bleeding, limb ischemia, revision of cannulation site, wound complications. Limb ischemia is defined as ischemia requiring any surgical procedure, including revision of the arterial/distal perfusion cannula, fasciotomy for compartment syndrome, gangrene, or amputation. Wound complication is defined as infection or requirement of an additional surgical intervention, such as arterial repair, washout with or without vacuum-assisted closure, and muscle flap closure. |
| Duration of ICU stay | Through study completion, up to 2 years | Intensive care unit length of stay |
| Duration of hospital stay | Through study completion, up to 2 years | Length of hospital stay |
Countries
China
Contacts
Primary ContactYang Yan
Backup ContactFengwei Guo
Outcome results
None listed